FDA issued three final guidances to industry regarding cancer clinical trials that parallel the goals of President Biden’s recently announced effort to renew and build upon his 2016 Cancer Moonshot initiative to facilitate continued advancement in cancer prevention, detection, research, and patient care (The Cancer Letter, Feb. 4, 2022).
Wednesday, March 8, marks six months since FDA failed to meet its court-ordered deadline to rule on all e-cigarette and other new tobacco product manufacturers’ applications.
The Pathology Department at Massachusetts General Hospital and Lunaphore, a Swiss life sciences company, entered a collaboration to develop an in vitro diagnostic that evaluates sensitivity of solid tumors to poly-ADP ribose polymerase inhibitors, with an initial focus on ovarian, breast, and prostate cancers.
FDA granted Fast Track designation for IO-202, a first-in-class myeloid checkpoint inhibitor targeting leukocyte immunoglobulin-like receptor B4 (LILRB4, also known as ILT3) for the treatment of patients with relapsed or refractory acute myeloid leukemia.
Foundation Medicine Inc. and Eli Lilly and Company entered a collaboration for the development of Foundation Medicine’s tissue- and blood-based assays as companion diagnostics for Retevmo (selpercatinib) and other therapies in Loxo Oncology at Lilly’s pipeline.
FDA is investigating a possible increased risk of death with the drug Ukoniq (umbralisib) approved to treat relapsed or refractory marginal zone lymphoma.
Veru Inc. and Eli Lilly and Company entered into a clinical trial collaboration and supply agreement to evaluate the efficacy and safety of enobosarm, Veru’s first-in-class, selective androgen receptor targeting agonist, in combination with Lilly’s Verzenio (abemaciclib), a CDK4/6 inhibitor, as a second line therapy in the treatment of AR+ER+HER2- metastatic breast cancer.
FDA granted Fast Track designation to the phase III registration program for enobosarm, a selective androgen receptor targeting agonist, for the treatment of androgen receptor positive, estrogen receptor positive, human epidermal growth factor receptor 2 negative (AR+ER+HER2-) metastatic breast cancer patients who have shown previous disease progression on a nonsteroidal AI, Faslodex (fulvestrant), and CDK 4/6 inhibitor therapy, and who have AR% nuclei staining ≥40% in breast cancer tissue (third-line metastatic setting).
Moderna Inc. and Carisma Therapeutics Inc. entered into a strategic collaboration agreement to discover, develop, and commercialize in vivo engineered chimeric antigen receptor monocyte (CAR-M) therapeutics for the treatment of cancer.
Cullinan Oncology Inc. and Icahn School of Medicine at Mount Sinai entered into a collaboration agreement to develop novel small molecule immune modulators.
